Sr. Manager, Microbiology Formulation Development

Role Summary

We are seeking a talented and driven Sr. Manager with expertise in microbiology to join the Formulation Development Group at Regeneron Pharmaceuticals Inc., located in Tarrytown, NY. In this role, you will oversee the operations of the microbiology testing laboratory, manage a team of microbiologists, supervise daily activities, and lead microbiological studies to support Regeneron’s product development, as well as testing for toxicology and clinical materials.

Responsibilities

• Conducting and overseeing microbiology research studies and experiments to support product development.
• Collaborating with cross-functional teams to design and execute microbiology studies that meet regulatory requirements and company standards.
• Developing and qualifying microbiological assays and methods to support drug development.
• Analyzing and interpreting microbiology data, generating reports, and presenting findings to key stakeholders.
• Managing and mentoring a team of microbiologists, providing guidance and ensuring high-quality work.
• Planning and executing microbiology-related projects and timelines.
• Communicating effectively with internal and external partners, including presenting at scientific conferences and representing the company in external collaborations.
• Engaging with leadership and extended leadership teams to advance product development.
• Maintaining accurate and detailed records of experiments and results in compliance with company policies and procedures.
• Identifying, investigating, and troubleshooting potential issues, and proposing solutions to ensure project success.
• Proactively identifying opportunities for process improvement and implementing changes to increase efficiency and effectiveness.
• Serving as a subject matter expert in microbiology, offering guidance and expertise to support product development.

Qualifications

• Required: BS or MS in Microbiology or a related field with 15+ years of pharmaceutical industry experience for BS, or 12+ years for MS; 8+ years of leadership experience.
• Preferred: Extensive knowledge of antimicrobial effectiveness testing, microbial challenge in-use studies, drug product sterility, manufacturing processes, and microbial risk assessment for facilities.
• Preferred: Proven experience developing and managing release testing of drug products and environmental monitoring programs.
• Preferred: Strong understanding of applicable regulations, including USP, ICH, and Ph. Eur., related to microbial testing.

Skills

• Program development and management in microbiology
• Cross-functional collaboration and effective communication
• Problem-solving, data analysis, and interpretation
• Leadership and team development

Education

• BS or MS in Microbiology or a related field (as specified above)